MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE APC 3; ARGON PLASMA COAGULATION UNIT

Model Number APC 3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Ulcer (2274)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

No anomalies were found in the device history records (dhrs) of the units.Most likely, there were many factors involved in the incident.Per provided documentation "pi does not believe this to be due to a device deficiency or malfunction.Per protocol, ulcer formation is considered anticipated ade associated with gma".Nevertheless, a thorough evaluation of the involved apc/esu system with the waterjet unit is being planned.If there are any issues with the equipment that could have caused or contributed to the event, a follow-up report will be filed.

Event Description

It was reported that an erbe system, argon plasma coagulator (apc)/electrosurgical unit [esu/generator, model vio 3, part number (p/n) 10160-000, serial number (s/n) (b)(6)] system with a waterjet model erbejet 2, p/n 10150-000, s/n (b)(6)] was involved in a patient incident after a treatment as part of the endoscopic gastric mucosal ablation (gma) as a primary obesity therapy early feasibility [comet ef] - step ii study.The equipment was used with an erbe hybrid apc probe (p/n 20150-015, lot number wo378668), erbe nessy return electrode (p/n 20193-074, lot number 220711-2401), and erbe waterjet pump cartridge (p/n 20150-300, lot number wo379463).The equipment settings were per the study protocol.Per provided documentation, the accessories used in the procedure (treatment) on (b)(6) 2023 were discarded.The following information was provided as part of the documentation for the study.Briefly describe the event: on (b)(6) 2023, patient (b)(6) presented to ed at 19:30.Patient reported three episodes of hematemesis, luq pressure, and nausea beginning at 19:00 on (b)(6) 2023.Ed reported patient as tachycardic but normotensive.Patient underwent endoscopic evaluation to second part of duodenum, performed by pi at 22:20.Findings included a large clot in the fundus, no active gastric bleeding, and large, clean-based ulceration in the greater curve of the stomach.Detail of action / treatment taken: chest x-ray: unremarkable.Ekg: sinus tachycardia, normotensive.Egd: clot was removed in piecemeal fashion with a snare.A suspected visible vessel was discovered at the very proximal, superior aspect of the ablation in a cratered area.2ml epinephrine, 2 hemostatic clips, and 3ml purastat were applied to the suspected vessel.Patient was admitted overnight for observation and prescribed carafate, 1g, qid.Treatment or medication administered: medication: epinephrine, dose (unit, route of administration): 2ml, submuc., date of first administration: (b)(6) 2023, date of last administration: (b)(6) 2023.Medication: purastat, dose (unit, route of administration): 3ml, submuc., date of first administration: (b)(6) 2023, date of last administration: (b)(6) 2023.Medication: carafate, dose (unit, route of administration): 1g, qid, oral, date of first administration: (b)(6) 2023, date of last administration: ongoing when reported on (b)(6) 2023 medication: pantoprazole, dose (unit, route of administration): 40mg, iv, date of first administration: (b)(6) 2023, date of last administration: (b)(6) 2023.

• Brand Name: ERBE APC 3
• Type of Device: ARGON PLASMA COAGULATION UNIT
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse 17; tubingen, germany 72072 ; GM 72072
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse 17; tubingen, germany 72072 ; GM 72072
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067-8764 ; 7709554400
• MDR Report Key: 18099941
• MDR Text Key: 327707896
• Report Number: 9610614-2023-00055
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APC 3
• Device Catalogue Number: 10135-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 126 KG
• Patient Ethnicity: Hispanic
• Patient Race: White